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510(k) Data Aggregation
K Number
K213587Device Name
MyCRO Band
Manufacturer
Otto Bock Healthcare LP
Date Cleared
2022-06-09
(209 days)
Product Code
MVA, OAN
Regulation Number
882.5970Why did this record match?
Applicant Name (Manufacturer) :
Otto Bock Healthcare LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, and scaphocephalic-shaped heads by applying mild pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. These devices are also indicated for adjunctive use for infants from 3 to 18 months of age synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, and scaphocephalic- shaped heads.
Device Description
The Ottobock MyCRO Band is a non-sterile temporary orthosis to aid in the correction of head shape caused by positioning in infants three (3) to eighteen (18) months of age. As such, this device is manufactured to match patient anatomy and may only be used on the patient for which the cranial orthosis was designed. The orthosis uses contact and growth zones to guide the growth of the head. The contact zones define limits for growth, while the growth zones leave space in areas required for forming the natural head shape. An adaptable closure allows for adjustability as the child grows. The orthosis is made of thermoplastic material with a soft, washable lining on the interior.
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K Number
K201426Device Name
MyCRO Band
Manufacturer
Otto Bock Healthcare LP
Date Cleared
2021-03-26
(301 days)
Product Code
MVA
Regulation Number
882.5970Why did this record match?
Applicant Name (Manufacturer) :
Otto Bock Healthcare LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, and scaphocephalic-shaped heads by applying mild pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. These devices are also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
Device Description
The Ottobock MyCRO Band is a non-sterile temporary orthosis to aid in the correction of head shape caused by positioning in infants three (3) to eighteen (18) months of age. As such, this device is manufactured to match patient anatomy and may only be used on the patient for which the cranial orthosis was designed. The orthosis uses contact and growth zones to guide the growth of the head. The contact zones define gentle limits for growth, while the growth zones leave space in areas required for forming the natural head shape. An adaptable closure allows for adjustability as the child grows. The orthosis is made of thermoplastic material with a soft, washable lining on the interior.
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